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#TEK Capital investee company #BELL Belluscura PLC – Orders for over 6,500 DISCOV-R™ received
LONDON, U.K. AND PLANO, TX, U.S. (16 August 2023). Belluscura plc (AIM: BELL), a leading medical device developer focused on lightweight and portable oxygen enrichment technology, announces that it has received purchase orders for over 6,500 of its next-generation DISCOV-R portable oxygen concentrator. This represents approximately $15 million of potential revenue to the Company, with initial production of the DISCOV-R expected to begin by the end of this quarter.
Following the pre-market launch of DISCOV-R and a patient usability study in June 2023, the Company plans a controlled roll out of the DISCOV-R this autumn and into 2024 to meet growing demand for the device amid substantial interest from medical device distributors, retailers, patients and durable medical equipment (DME) providers, among others.
The DISCOV-R is expected to be the world’s first ambulatory two litre continuous flow, eight level pulse dose portable oxygen concentrator when it is released. With the ability to produce two litres of continuous flow and maximum single pulse dose volumes exceeding 110ml, the Company believes that the DISCOV-R will be covered by both CMS E1390 (stationary) and E1392 (portable) reimbursement codes, making the DISCOV-R a better financial option for the thousands of homecare oxygen providers. It will also produce nearly three times as much oxygen by weight than its dual flow competitors.
The recent purchase orders follow the signing of several distribution agreements with medical device distributors and other home healthcare providers, including a distribution agreement with a division of McKesson, one of the largest distributors of pharmaceuticals and medical devices in North America, earlier this month and a marketing agreement with GoodRx®, a leading digital healthcare platform, in February 2023. The Company has received multiple additional requests from leading oxygen homecare providers in the US to distribute the DISCOV-R.
The Company will update the market later this year as it plans its controlled roll out of the DISCOV-R this autumn and into 2024.
Substantial progress on X-PLOR® and proprietary NOMAD biometric app
At the same time, the Company continues to progress its CE and UKCA registration mark application for its X-PLOR® portable oxygen concentrator. Since resources in the US were redirected to completing the development and launch of the DISCOV-R, production of X-PLOR by our Chinese partner, Innomax Medical Technology Ltd (Innomax), has now progressed, with 1,500 units recently being manufactured and shipped to the US for distribution.
The Company recently established a subsidiary and hired its first employees in Shenzhen, China as it prepares for the anticipated registration of the X-PLOR for sale and distribution in China and Hong Kong later this year. The Company and Innomax believe there is a significant market opportunity in China with approximately 100 million people suffering from COPD.
Additionally, the Company continues to drive innovation in telemedicine and artificial intelligence with its proprietary NOMAD biometric app. The NOMAD app will allow users of the DISCOV-R to track performance data on their concentrator and connected devices such as an Apple® or Samsung® Watch, FitBit® device or Nonin® and Masimo® pulse oximeters. The collective information can then be provided to a patient’s healthcare provider in person or remotely.
The Company is already working on the next-generation NOMAD app that will alert patients when their blood oxygen saturation level has varied beyond parameters set by their doctor, which is expected to help patients better monitor their conditions, but also improve the efficiency of the device by delivering supplemental oxygen as needed.
Bob Fary. Sr Vice President of Global Sales, Belluscura plc, commented:
“We are very excited about the overwhelming interest in the DISCOV-R by online retail sellers and other medical equipment providers. Following the pre-market launch of the product and the patient usability study in June, initial feedback suggests we will receive the same or greater level of interest from leading home healthcare providers once it is launched commercially.”
Bob Rauker, Chief Executive Officer, Belluscura plc, commented:
“We believe the DISCOV-R, combined with our proprietary NOMAD app, will be transformational to the portable oxygen industry and patient outcomes. This is reflected by early demand for the product prior to its full commercial launch, which is expected to take place later this year. The significant number of orders received demonstrates the substantial appetite for this product and we anticipate adding several more of these providers to our distribution network as we balance the high demand with production expectations over the next twelve months.
“This marks another exciting development for the Company, delivering on our strategy to design and manufacture highly differentiated, high quality and high margin products. Amid growing sales and continued progress with our X-PLOR device and NOMAD app, we continue to seek further opportunities to improve the quality of life for our end users”.
For further information please contact:
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Belluscura plc |
Tel: +44 (0)20 3128 8100 |
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Adam Reynolds, Chairman |
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SPARK Advisory Partners Limited Nominated Adviser |
Tel: +44 (0)20 3368 3550 |
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Neil Baldwin / Jade Bayat |
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Dowgate Capital Limited Broker |
Tel: +44 (0)20 3903 7715 |
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James Serjeant / Russell Cook |
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MHP Financial PR & Investor Relations |
Tel: +44 (0)20 3128 8100 email: Belluscura@mhpgroup.com |
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Katie Hunt/Matthew Taylor |
#POLB Poolbeg Pharma PLC – Annual Report & AGM Notice
Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’), a leading biopharmaceutical company focusing on infectious and prevalent diseases with a high unmet medical need, confirms that the Company’s Annual Report and Accounts for the period ended 31 December 2022 and the notice of Annual General Meeting (“AGM”) 2022 have been posted to shareholders.
The 2022 Annual Report and Accounts, the Notice of AGM and accompanying form of proxy are available to download from the Company’s website: https://www.poolbegpharma.com/investors/documents/
The Annual General Meeting will be held at the offices of DAC Beachcroft LLP, 25 Walbrook, London EC4N 8AF, United Kingdom on 11 May 2023 at 12pm.
– Ends –
Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 (0) 207 183 1499 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM)
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+44 (0) 207 220 0500 |
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Singer Capital Markets (Joint Broker) Phil Davies, Sam Butcher
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+44 (0) 207 496 3000 |
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
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Optimum Strategic Communications Mary Clark, Nick Bastin, Vici Rabbetts
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+44 (0) 208 078 4357 |
About Poolbeg Pharma
Poolbeg Pharma specialises in the development of innovative medicines to address the unmet need in infectious and other prevalent diseases. Poolbeg has a disciplined portfolio approach to mitigate risk, accelerate drug development, and enhance investor returns. The Company simultaneously advances multiple programmes in cost-effective clinical trials, rapidly generating early human safety and efficacy data to enable early partnering / out-licensing, with the funds generated reinvested in the pipeline. Poolbeg also uses AI to interrogate human challenge trial data sets to quickly identify new targets and drugs, and in-license near or in the clinic medicines, leading to faster development and greater commercial appeal.
The Company is targeting the growing infectious disease market. In the wake of the COVID-19 pandemic, infectious disease has become one of the fastest growing pharma markets and is expected to exceed $250bn by 2025. Through opportunistic identification of assets which complement Poolbeg’s existing pipeline, the Company is progressing programmes in oncology and metabolic syndromes; adding disease areas with significant addressable markets.
With its initial assets from hVIVO plc (formerly Open Orphan plc), an industry leading infectious disease and human challenge trials business, Poolbeg has access to knowledge, experience, and clinical data from over 20 years of human challenge trials. The Company is using these insights to acquire new assets as well as reposition clinical stage products, reducing spend and risk. Amongst its portfolio of exciting assets, Poolbeg has a small molecule immunomodulator for severe influenza and other acute inflammatory conditions (POLB 001) which produces a highly significant reduction in p38 MAP kinase driven cytokines in a clinical setting; a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002); and a vaccine candidate for Melioidosis (POLB 003). The Company is also developing two Oral Delivery Programmes and is progressing two Artificial Intelligence (AI) Programmes to add promising new assets to its pipeline.
For more information, please go to www.poolbegpharma.com or follow us on Twitter and LinkedIn @PoolbegPharma.
#POLB Poolbeg Pharma – POLB 001 Patent Portfolio Strengthened
Key highlights
· Patent granted for use of certain p38 MAP kinase inhibitors for the treatment of hypercytokinaemia
· Allows for use in combination with an antiviral agent
· Patent enhances the robust IP portfolio protecting Poolbeg’s growing pipeline
8 March 2023 – Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’), a leading infectious disease focused biopharmaceutical company, announces that further to its announcement on 4 October 2022, it has been granted a patent by the US Patent and Trademark Office (USPTO) for methods of treating hypercytokinaemia using POLB 001, a small molecule immunomodulator being developed to address the unmet medical need arising from severe influenza and other acute inflammatory conditions.
The USPTO granted a patent for the use of POLB 001 and related p38 MAP kinase (mitogen-activated protein kinase) inhibitors for the treatment of hypercytokinaemia (or “cytokine storm”), including hypercytokinaemia that occurs due to viral infection such as an influenza virus, cancer or an autoimmune response, through the modulation of the immune response (reducing the body’s hyperinflammatory response).
Poolbeg has a worldwide license for POLB 001 for all uses in humans and is developing a strong IP portfolio with US patent protection in place covering the use of a wide range of p38 MAP kinase (mitogen-activated protein kinase) inhibitors for the treatment of symptoms of severe influenza and hypercytokinaemia and a European patent for the class of p38 MAP kinase inhibitors for use in the treatment of severe influenza.
In January 2022, the Company filed a patent application to seek class protection for the novel use of p38 inhibitors in CAR T cell treatment. This opens up a significant new market opportunity for POLB 001 beyond severe influenza. Poolbeg continues to explore opportunities to expand its IP around this asset to cover new disease areas which could enhance the value of the asset.
The Company continues to work with its patent advisors to broaden and expand its patent families.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said:
“We are expanding our IP portfolio across the globe, allowing us to continue advancing and protecting our programmes for the treatment or prevention of severe influenza and hypercytokinaemia. Enhanced IP protection of our assets across key markets, such as the US, increases the overall value and attractiveness of these products to potential partners. This is particularly important in the light of the recent favourable results from our POLB 001 LPS human challenge trial announced 2 March 2023.”
About POLB 001
POLB 001 is a small molecule immunomodulator for the treatment of symptoms of severe influenza, and hypercytokinaemia which may occur due to exposure to a pathogen or be triggered by cancer or an autoimmune response. Poolbeg continues to discover new indications for POLB 001 in other acute inflammatory conditions. POLB 001 selectively inhibits overwhelming inflammation that may be triggered by viral infections, such as severe influenza, while leaving the necessary immune functions intact to fight the infection. This contrasts with other immunomodulatory approaches, such as steroids, which affect both beneficial and damaging immune responses. Due to its mode of action it is strain agnostic and unaffected by seasonal variants which is a significant advantage over treatments available on the market. In addition, as a shelf stable oral drug it is an ideal stock piling candidate for both seasonal and pandemic outbreaks. Therefore, POLB 001 has the potential to be a transformational treatment for patients and to become a leading severe influenza treatment.
Cytokines, originally intended to optimise immunity, when overexpressed can sweep throughout the body re-programming white blood cells causing tissue damage, shutting down circulation and other essential organs leading to death and in certain circumstances cytokine storm or cytokine release syndrome (CRS). Such excessive cytokine responses can be seen in diseases as diverse as severe influenza and in response to chimeric antigen receptor T cell therapy (CAR T cell) treatment of cancers. Poolbeg continues to evaluate POLB 001’s potential in additional indications to fully unlock the potential value of the molecule.
p38 MAP kinase (p38 MAPK) is a master regulator of immunity, ubiquitously expressed in all white blood cells where it is poised to unleash inflammation. Poolbeg’s clinical approach, inhibiting p38 MAP kinase hypothesised that it’s a prime suspect in driving the cytokine storm and its consequences in patients whose immune responses do not resolve normally, without intervention. This has now been demonstrated as a concept in a human clinical model of infectious disease and endotoxin mediated inflammation administering LPS as the endotoxin to healthy volunteers. LPS is a bacterial product that mimics infection and is used to capture the hallmarks of both local and systemic inflammation typical of a cytokine storm in humans, but in a safe, controlled and quantifiable manner – it’s one step removed from the infected critical care patient. Treatment with POLB 001 resulted in a highly significant reduction in p38 MAP kinase driven cytokines and exhibited a marked reduction in multiple markers of systemic and local inflammation compared with placebo. Read more here.
#TEK Tekcapital PLC investee co #BELL Belluscura PLC – appoints Senior VP of Global Sales
Belluscura plc (AIM: BELL), a leading medical device developer focused on lightweight and portable oxygen enrichment technology, announces that Robert (“Bob”) Fary has joined the Company as Senior Vice President of Global Sales.
Bob has thirty-years of experience in the respiratory industry where he has held leadership roles at major oxygen concentrator manufacturers and durable medical equipment companies. During the past two decades, Bob’s industry leading team was directly responsible or contributed to the sale of over 1 million portable oxygen concentrators (“POCs”), generating revenues in excess of $1 billion.
Commenting on the hire, Robert Rauker, Chief Executive Officer, Belluscura plc, said:
“We are very excited that Bob has joined our team as we enter the next stage of growth at Belluscura. His deep knowledge of the portable oxygen concentrator sector and its channels to market will be invaluable as we build on our success to date to bring our latest generation of POCs to market.”
Bob Fary, Senior Vice President of Global Sales, commented:
“I am delighted to have joined Belluscura at this important juncture for the Company as it captures the demand in its markets for its best-in-class products. The planned launch of DISCOV-R will be another exciting step in meeting the needs of patients around the world. I look forward to working alongside the wider executive team to grow the Company’s sales in the US and beyond.”
For further information, please contact:
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Belluscura plc |
www.belluscura.com |
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Robert Rauker, Chief Executive Officer |
via MHP |
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Anthony Dyer, Chief Financial Officer |
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SPARK Advisory Partners Limited (NOMAD) |
Tel: +44 (0)20 3368 3550 |
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Neil Baldwin |
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Dowgate Capital Limited (Broker) |
Tel: +44 (0)20 3903 7715 |
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James Serjeant / Nicholas Chambers |
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MHP (Financial PR and Investor Relations) |
Tel: +44 (0)20 3128 8100 |
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Katie Hunt / Pete Lambie / Matthew Taylor |
Email: belluscura@mhpgroup.com |
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About Belluscura plc ( www.belluscura.com )
Belluscura is a UK medical device company focused on developing high performing, lightweight and portable oxygen enrichment technology used in a broad range of industries and therapies. Our innovative oxygen technologies are designed with a global purpose: to create improved health, mobility and economic outcomes for patients, healthcare providers and insurance organisations.
#TEK TekCapital Plc investee co. #BELL Belluscura Plc – Year-end Trading Update
LONDON, U.K. AND PLANO, TX, U.S. (13 January 2023) Belluscura plc (AIM: BELL), a leading medical device developer focused on lightweight and portable oxygen concentrator (“POC”) technology, provides a trading update for the year ended 31 December 2022.
The Group is pleased to announce that it has made considerable progress this year. Since the launch of the 1st generation X-PLOR in September 2021, the Group is now distributing throughout the US through multiple sales channels: Distributors and Durable Medical Equipment Providers both Online and Bricks and Mortar, Medical Supply Warehouses, Medical Device Intermediaries, Hospitals and Direct to Consumer.
In addition, the collaboration agreement with the VGM Group has already resulted in 17 new distribution agreements in the last 3 months, including the agreement with a leading durable medical equipment provider and distributor in the US, announced in September 2022, which serves nearly 2 million patients both online and through over 1,000 locations.
In December 2022 we also signed our first international distribution agreement, with MedHealth Supplies of South Africa, which sells to one of the world’s leading respiratory device suppliers. We have already received orders for over 1,000 units, with their first shipment sold out within 48 hours.
In December we produced a record 536 units in our in-house facility and with Innomax coming on-line in Q1 this will more than double production of X-PLOR. Of important note, even with the rapid increase in volume, the production quality of our in-house facility has been outstanding, with no units returned due to defects.
By 31 December 2022 the Company had shipped or received orders for 2,850 X-PLOR units with 1,226 units being shipped in 2022 (2021: 377). As at the year end, the Adjusted EBITDA1 loss is anticipated to be in line with market expectations and retained cash balances of $1.8 million, which together with inventory and inventory deposits, amounted to $11.9 million.
The next generation X-PLOR, launched in September 2022, has been well received by the market based upon its performance and reliability. It provides more oxygen by weight than any portable oxygen concentrator in its class and is the first POC with a mobile app that connects to phones, tablets, pulse oximeters and wearables (the NOMAD Biometric App).
The first DISCOV-RTM POCs expect to be launched for pre-market evaluation in Q1 2023, with full commercialisation anticipated in Q2. DISCOV-R is the first ambulatory pulse-dose and two-litre continuous flow POC in the world. Weighing c.40% less than any comparable dual flow oxygen concentrator on the market, the DISCOV-R produces nearly 3 times the oxygen by weight than its competition. Distributors are very excited about DISCOV-R and it is already receiving pre-orders. The DISCOV-R will also include the transformational NOMAD Biometric App.
In March 2022, we signed a manufacturing Master Supply Agreement (“MSA”) with InnoMax Medical Technology, Ltd (“InnoMax”) to manufacture the X-PLOR portable POC in China, more than doubling our manufacturing capacity in 2023 and enabling us to accelerate our international expansion by opening up markets in Asia and beyond. Innomax are anticipated to directly source most of their own components from the second half of 2023, which will also result in a significant margin improvement and reduction in the Company’s inventory levels.
Given the strong demand, the Group took the decision to transfer its US manufacturing in-house, to increase production output at high quality standards, and achieve a significant reduction in production costs. This was successfully completed at the end of July 2022, enabling the achievement of ISO:13485 accreditation. The manufacturing facility is already demonstrating the required product quality to build a significant customer base and repeat orders, underpinning the building of a strong brand reputation for our best-in-class technology.
Following this transition and having achieved ISO13485 accreditation, we are confident in having both the quality of manufacturing facilities and the inventory levels to increase production commensurate with market demand, as we expand our sales channels and are able to apply to distribute products internationally.
Robert Rauker, CEO of Belluscura plc, commented: “During the year we have made considerable progress. We have enhanced our production, quality accreditation and supply chain, positioning us well to deliver on the demand we are seeing for our devices, as we expand our distribution partners and geographical reach. Market reception for the next generation X-PLOR and Nomad App has been extremely positive, with an encouraging level of forward orders. We are very excited about the upcoming launch of the DISCOV-R, which we believe will be a transformational product, and we look to the future with confidence.”
Adjusted EBITDA is earnings before interest, tax, depreciation, amortisation, share-based payment expense, foreign exchange movements and non-recurring items.
For further information please contact:
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Belluscura plc |
www.belluscura.com |
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Robert Rauker, Chief Executive Officer |
via MHP |
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Anthony Dyer, Chief Financial Officer |
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SPARK Advisory Partners Limited (NOMAD) |
Tel: +44 (0)20 3368 3550 |
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Neil Baldwin |
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Dowgate Capital Limited (Broker) |
Tel: +44 (0)20 3903 7715 |
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James Serjeant / Nicholas Chambers |
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MHP (Financial PR and Investor Relations) |
Tel: +44 (0)20 3128 8100 |
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Katie Hunt / Pete Lambie / Matthew Taylor |
Email: belluscura@mhpgroup.com |
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About Belluscura plc (www.belluscura.com)
Belluscura is a UK medical device company focused on developing oxygen enrichment technology spanning broad industries and therapies. Our innovative oxygen technologies are designed with a global purpose: to create improved health and economic outcomes for the patients, healthcare providers and insurance organisations.
#ORPH Open Orphan PLC – CAP accreditation
Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that its clinical laboratories in Queen Mary’s Bioenterprise Centre and Plumbers Row (hLab) have been awarded accreditation by the College of American Pathologists (“CAP”). The Company sought the accreditation as part of its ongoing commitment to maintaining best in class quality systems.
The CAP is the world’s largest organisation of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programmes. The accreditation “supports laboratories performing testing on specimens from human, using methodologies and clinical application within the expertise of the program”. This further expands on the Company’s Good Clinical Practice for Laboratories (GCLP) accreditation from the Medicines and Healthcare products Regulatory Agency (MHRA) and provides additional quality assurances of its laboratory services for its clients, especially within the United States, thus ensuring the accuracy of test results and conforming to the requirements from the US Food and Drug Administration (FDA).
hLab is a highly specialised virology and immunology laboratory, offering a suite of services to support both pre-clinical and clinical respiratory drug and vaccine discovery and development. This includes assay development, transfer and optimisation across immunology, molecular and cell-based assays, including extensive options in sample matrix and stability testing and analysis. hLab is well equipped with Biosafety Level 2 and 3 facilities to provide high quality data outputs to enable clients to achieve early proof of concept, or to make a breakthrough discovery in the pathology and possible treatment of diseases with unmet medical needs. hLAB now provides services beyond supporting the Company’s in-house human challenge trials, offering lab services as a standalone service to s upport vaccine and drug development from pre-clinical studies through Phases I – III clinical trials.
Brandon Londt, Development Operations Director, hLab Development at hVIVO, said : “We are proud to have received the CAP accreditation, which is recognition of the quality of our laboratory and further demonstrates our commitment to maintaining the highest standards of excellence and ensuring that our work practices meet the rigorous CAP assessment standards. This accreditation will provide current and future clients a further degree of confidence in the quality of work performed in our laboratory and assurances of the results we produce.”
For further information please contact:
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Open Orphan plc |
+44 (0) 20 7756 1300 |
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Yamin Khan, Chief Executive Officer |
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Walbrook PR (Financial PR & IR) Stephanie Cuthbert / Phillip Marriage / |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0) 7796 794 663 / +44 (0) 7867 984 082 / |
Tim McCarthy , Non-Executive Chairman of ImmuPharma (AIM:IMM) Interviewed on ShareTalk
ImmuPharma focuses on developing pioneering and novel drugs in specialist therapeutic areas. We are an ethical organisation with the vision to develop novel drugs to treat serious medical conditions, delivering value to patients, medical professionals, healthcare payers and our shareholders.
We value innovation, creativity, integrity, fairness, competency, professionalism, and we have a passion for what we do.
Tim McCarthy, Chairman of ImmuPharma firmly committed to Lupuzor™ ahead of the start of the Managed Access Programme
ImmuPharma’s strategy and business model are different from many of its peers. We are a risk-averse company and our management team has extensive experience in senior positions in some of the world’s leading pharmaceutical companies. We focus on developing pioneering and novel drugs in specialist therapeutic areas where there is a distinct lack of existing treatments, avoiding primary care (diseases treated by GPs) where many treatments exist. This is consistent with the trends in the pharmaceutical industry. Since our foundation, our research strategy has been to work closely with the largest fundamental research organisation in Europe, the Centre National de la Recherche Scientifique, (CNRS) in France. This collaboration enables us to access innovative research with substantial embedded value and to work with many leading scientists and doctors. ImmuPharma has exclusive rights to all its intellectual property assets. Our market strategy is to license our assets to leading international corporations that are well-placed to further develop and/or commercialise our drugs. Our corporate deal with Cephalon Inc. in 2008, for the worldwide rights of our lead drug candidate for the treatment of Lupus, Lupuzor™ is one example of this strategy in action.